PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study (PREDICT)
Prognostic Value of Photon-Counting Detector CT-Derived High-Risk Coronary Plaque Features for Predicting Major Adverse Cardiovascular Events: a Prospective Cohort Study
Study Overview
Status
Detailed Description
Photon-Counting Detector CT (PCCT) enables improved spatial resolution and spectral tissue characterization, allowing non-invasive detection of high-risk coronary plaque (HRP) features such as low-attenuation plaque (<30 HU), positive remodeling (index ≥1.1), spotty calcification, and the napkin-ring sign. The presence of ≥2 of these features defines a PCCT-detected high-risk plaque. Optical Coherence Tomography (OCT), an invasive high-resolution imaging tool, defines HRP by thin-cap fibroatheroma (fibrous cap thickness <65 μm, lipid arc >90°) and other vulnerable features. While OCT provides detailed information on plaque vulnerability, it is invasive and limited to selected vessels. The prognostic significance of PCCT-defined HRP, and its diagnostic agreement with OCT, remain to be fully established.
This prospective, single-centre study will enroll patients with acute or stable coronary syndromes who are scheduled for clinically indicated invasive coronary angiography and OCT evaluation of at least one native coronary artery. All participants will first undergo a dedicated contrast-enhanced PCCT coronary angiogram. Within 30 days after PCCT, participants will undergo invasive coronary angiography with OCT imaging. Thus, OCT is systematically acquired after the CT, allowing a cross-sectional diagnostic comparison where PCCT findings are evaluated against the OCT reference. Both imaging datasets will be analyzed by independent core laboratories blinded to each other's results and to clinical data.
The study has two integrated components:
- Prognostic component - The primary objective is to assess whether the presence of PCCT-defined HRP independently predicts the 2-year incidence of MACE (cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina requiring urgent revascularization). The primary hypothesis is that MACE rate is significantly higher in patients with PCCT-HRP than in those without.
- Cross-sectional diagnostic comparison - Using OCT as the invasive reference, the diagnostic performance of PCCT for identifying high-risk plaque will be determined. Per-patient and per-lesion sensitivity, specificity, positive and negative predictive values, and overall accuracy of PCCT will be calculated and compared with OCT-derived high-risk plaque classification.
Participants will be followed prospectively for MACE and unplanned revascularization over 24 months.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bin Tu, MD.PhD
- Phone Number: +8618810682692
- Email: dr_bintu@163.com
Study Locations
-
-
China
-
Beijing, China, China, 10000
- Recruiting
- Beijing Chaoyang Hospital，Capital Medical University, Beijing
-
Contact:
- Bin Tu, MD, PhD
- Phone Number: +8618810682692
- Email: dr_bintu@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Scheduled for clinically indicated, non-emergent invasive coronary angiography
- Provision of written informed consent and willingness to comply with long-term follow-up
Exclusion Criteria:
- Estimated glomerular filtration rate <45 mL/min/1.73 m²
- Known allergy to iodinated contrast media
- Pregnancy or breastfeeding
- Persistent atrial fibrillation or other arrhythmia precluding adequate ECG-gated CT acquisition
- Body mass index >40 kg/m²
- Target vessel with a previously implanted stent
- Life expectancy <2 years or any condition that, in the opinion of the investigator, makes follow-up unlikely or participation inappropriate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
PCCT High-Risk Plaque Group
Participants with PCCT-defined high-risk plaque in at least one native coronary artery.
High-risk plaque is defined as the presence of ≥2 of the following features on PCCT: low-attenuation plaque (<30 Hounsfield Units), positive remodeling (remodeling index ≥1.1),
spotty calcification (<3 mm), and the napkin-ring sign.
|
|
PCCT Non-High-Risk Plaque Group
Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of major adverse cardiovascular events (MACE)
Time Frame: Up to 24 months
|
Incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and hospitalization for unstable angina requiring urgent revascularization, stratified by the presence versus absence of PCCT-defined high-risk plaque.
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Per-lesion MACE
Time Frame: Up to 24 months
|
Per-lesion hazard ratio of MACE for PCCT-defined HRP and OCT-defined HRP, adjusted for baseline clinical risk factors
|
Up to 24 months
|
|
Myocardial infarction
Time Frame: Up to 24 months
|
Time to first non-fatal myocardial infarction
|
Up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque
Time Frame: up to 12 month
|
per-patient and per-lesion sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve
|
up to 12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-ke-1040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.